About this trial
Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: (1) To evaluate the feasibility of a multicenter randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, and outcome ascertainment; (2) To establish the change in pre-transplant dyspnea perception, diaphragm structure and function, health related quality of life (HRQoL) and post-transplant intensive care unit (ICU), hospital and post-transplant 3-month outcomes with IMT relative to usual care group; and (3) To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area (CSA), oxidative capacity, inflammatory markers and post-transplant diaphragm muscle thickness and function (UHN TGH site).
Eligibility criteria
Qualifiers
Adult participants (≥ 18 years of age)
Lung Transplant Candidates
Participating in outpatient pulmonary rehabilitation (standard of care)
Diagnosis of Interstitial Lung Disease or Chronic Obstructive Pulmonary Disease
Disqualifiers
Respiratory exacerbation within the last 1 month
Neurologic or musculoskeletal conditions that may interfere with IMT or functional assessments (i.e. history of stroke, severe arthritis of hands)
Insufficient English fluency to provide informed consent or to follow study protocols
Any evidence of pneumothorax on recent imaging (< 6 months)
Trial design
Treatments tested in this trial
- IMT and exercise training group
Treatment groups
Sponsors and collaborators
University Health Network, Toronto
Lead sponsor
Canadian National Transplant Research Program
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Ozmosis Research Inc.
Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Vancouver General Hospital
Collaborator